LOW BIRTH WEIGHT IN MINORITY POPULATIONS

Release Date:  January 22, 1999

PA NUMBER:  PA-99-045

P.T.

National Institute of Nursing Research
National Institute of Dental and Craniofacial Research
National Institute of Environmental Health Sciences
National Institute of Child Health and Human Development

PURPOSE

The National Institute of Nursing Research (NINR), the National Institute of
Dental and Craniofacial Research (NIDCR), the National Institute of Environmental
Health Science (NIEHS) and the National Institute of Child Health and Human
Development (NICHD) invite the submission of research grant applications relevant
to low birth weight (LBW) in minority populations. This program announcement
solicits research to expand our understanding of the underlying mechanisms that
contribute to the ethnic variations in LBW and strategies for prevention. The
goals of this program announcement are: (1) development of innovative strategies
to prevent LBW in minority populations; (2)expanding our understanding of how
psychosocial and environmental factors affect or interact with the biologic
mechanisms that influence pregnancy outcomes.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Program Announcement (PA), Low Birth
Weight in Minority Populations, is related to the priority areas of maternal and
infant health, educational and community-based programs, nutrition, alcohol and
other drugs, HIV infections and sexually transmitted diseases.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies of the
Federal Government. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism. Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. The total project
period for an application submitted in response to this PA may not exceed five
years.

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact Institute or Center (IC)
program staff (see INQUIRIES, below) before submitting the application, i.e., as
plans for the study are being developed. Furthermore, the applicant must obtain
agreement from IC staff that the IC will accept the application for consideration
for award. Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute or Center who agreed to accept
assignment of the application. This policy requires an applicant to obtain
agreement for acceptance of both any such application and any subsequent
amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998
(http://www.nih.gov/grants/guide/notice-files/not98-030.html).

BACKGROUND

Low birth weight (LBW) is a major public health problem in the United States,
contributing substantially to both infant mortality and to childhood physical
impairment.  Although infant mortality in the United States has declined steadily
over the past several decades and is at a record low of 7.2 per 1,000 live births
(National Center for Health Statistics, 1997), the United States still ranks 20th
in infant mortality compared with other industrialized nations, largely due to
its high LBW rate.

Over the past decade, the rate of low birth weight births (LBW) (less than 2500
grams) has slowly increased to 7.6%, the highest rate reported since 1976
(Ventura et al, 1998). Forty per-cent of the deaths in this population occur in
infants less than 1500 grams (VLBW), with the highest death rate taking place in
extremely low birth weight infants (ELBW) who weigh less than 1000 grams
(Faneroff et al, 1995). Although the causes of ELBW and VLBW infant births differ
from that of LBW infants  in some regards, there may be significant overlap
especially in the impact of psychosocial and environmental factor.

There is ethnic variation in the rates of LBW. The prevalence of LBW among
African-Americans is more than double that of whites, 13.1% and 6.4%
respectively. Among infants of Asian origin, rates of LBW ranged from 5.0-7.9%
and 6.1-9.3% for those of Hispanic origin (Ventura et al, 1998). Although African
Americans are at two to three times greater risk for poor pregnancy outcomes,
this disparity occurs in other minority populations as well. For instance, Puerto
Rican women have higher rates of LBW compared to whites, and there are variations
in patterns of LBW in Asian women (Le et al, 1996). These disparities are
commonly attributed to adverse economic and social conditions. However,
adjustment for economic and social factors does not usually eliminate ethnic
difference. In a study comparing well-educated African American and white women,
the disparity remained despite the controlling for education as a proxy for
socioeconomic status (Collins et al, 1997).

The strong association between LBW and preterm delivery places LBW children at
risk for neurosensory, developmental, physical, and psychological problems.
Cerebral palsy is a major neurologic abnormality in LBW occurring much more
commonly in LBW infants that their normal weight peers.  The incidence of CP is
inversely related to birth weight; the ELBW infants have the highest incidence
(Vohr, et al, 1998). Additionally, LBW children are at risk for lower scores on
intelligence tests and developmental delay. As a group, LBW children experience
more health problems, such as asthma, upper and lower respiratory infections and
ear infections.

A decade ago, the costs associated with LBW were estimated at more than $5.4
billion, with 75% of these costs due to infant care. Approximately 10% of annual
health care expenditures for children result from LBW-related problems.  As the
low birth weight rate increases, these costs increase as well.

The exact causes of LBW are not known. Although not the total picture, three
major risk factors account for a large proportion of all LBW births: cigarette
smoking during pregnancy, low maternal weight gain and low pre-pregnancy weight.
Perinatal mortality rates are twice as high in smokers as nonsmokers and smoking
mothers are more likely to deliver LBW and premature infants. In spite of this
knowledge we do not know the exact causes or the relationships that explain these
effects. Additionally, intervention directed toward these risk factors have not
been effective in reducing low birth weight rates.

Other modifiable causes of LBW include genital tract and oral microbial
infections and inflammation, poverty, social support, stress and its correlates,
housing (i.e. physical environment such as lead paint, safety, crowding,
pollution), community resources, toxic habits including smoking, alcohol use
during pregnancy and risky behaviors and exposure to violence. Associations with
modifiable causes of low birth weight have been demonstrated in the literature
but the underlying biologic mechanisms are poorly understood.

Current thinking indicates that prenatal programs fail to decrease LBW because
the intervention is too late. This supports the need for preconceptional and
interconceptional care to reduce adverse pregnancy outcomes and thus reduce
medical care costs. There is little research, however, to demonstrate their
effectiveness or cost savings.

Recently, there has been a shift in the evaluation of prenatal care and its
effectiveness from one of the frequency of contact to the content of each
contact. Further research on the individual components of prenatal care and their
impact on LBW is needed.

The impact of cultural beliefs and practices on pregnancy outcome is poorly
understood. Although information on the exact nature of these practices exists,
knowledge of the mechanisms of action on pregnancy outcome is sparse.

Unraveling the underlying reasons for ethnic variations in LBW and preterm
delivery is one of the greatest challenges to research in this area. Our ability
to understand these variations is limited by our incomplete understanding of the
underlying biologic mechanisms that are responsible.

RESEARCH OBJECTIVES

Clinical and basic research that address questions pertaining to the goals of
this PA (See PURPOSE) will be considered responsive.

The following are offered as illustrations of topics that would be responsive to
this PA. Applications need not, however, be limited to these specific issues:

(1) investigation of the interrelationships between biological mechanisms and
social, psychological, and contextual factors in minority populations. Expanding
the understanding of the role of genetics in the etiology of LBW to define
susceptible subpopulations for future investigation;

(2) development and testing of interventions, including the effectiveness of
social supports, home visitation, and other approaches that mediate adverse
psychological, social, and environmental effects, and improve or prevent
microbial infections and inflammation;

(3) investigation of the effects and interrelationships  among psychosocial and
environmental factors such as poverty and other factors on pregnancy outcomes;

(4) investigation of psychosocial stress, violence, physical environment (home,
safety, access to goods and services, rural vs. urban), immigration,
acculturation  and other environmental and occupational factors and their
relationship to physical factors such as microbial infections and inflammation,
immune status, chronic stress and optimal pregnancy maintenance;

(5) development and testing of interventions to lengthen interpregnancy
intervals, improve nutritional status, reduce microbial infections and
inflammation, modify behavior, lengthen breastfeeding duration and promote
adequate weight gain during pregnancy;

(6) investigation of the content of prenatal and preconceptional care, access to
care and linkages with public health and social services and culturally competent
care;

(7) investigation of the effects of culture on diet patterns and physical
activity during pregnancy and its relationship to pregnancy outcome;

(8) investigation of the role of environmental and occupational factors (i.e.
exposure to chemicals in the home and work environment, indoor and outdoor air
pollution, contaminants in the food supply) in the causes of LBW in minority
populations.

(9) laboratory research on the cellular and genetic mechanisms by which
environmental or other factors work during pregnancy to result in infant of LBW.

(10) prevention of VLBW and ELBW including the mechanisms that result in this
condition as well as diagnosis and treatment strategies.

(11) investigation into the diagnosis, mechanisms and treatment of intrauterine
growth restriction

(12) laboratory research on the mechanisms (genetic, immunologic, endocrine,
metabolic, physiologic, etc.) which result in VLBW and ELBW deliveries.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 20, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994 available on the web at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not94-105.html

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not to
include them. This policy applies to all initial (Type 1) applications submitted
for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
[email protected].

The number and title of this program announcement must be typed in Section 2 on
the face page of the application.

The complete original and five signed, legible copies must be sent or delivered
to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines. Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in accordance with
the standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority score,
and receive a second level review by the appropriate national advisory council
or board, when applicable.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written review, comments on the following aspects of the application will be made
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will be
addressed and considered in the assignment of the overall score.

(1) Significance.  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive this
field?

(2) Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well- integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation.  Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator.  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

(5) Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research. Plans for
the recruitment and retention of subjects will also be evaluated.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to that Institute. Award criteria that will be used to make
award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions from
potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Cara J. Krulewitch, CNM, PhD
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN-12 MSC 6300
Bethesda, MD 20892-6300
Telephone:  (301) 594-2542
FAX:  (301) 480-8260
Email: [email protected]

Dennis F. Mangan, Ph.D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-32F, MSC 6402
Bethesda, MD 20892-6402
Telephone:  (301) 594-2421
FAX:  (301) 480-8318
Email: [email protected]

Gwen Collman, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-4980
FAX: (919) 541-4937
Email: [email protected]

Jonelle R. Rowe MD
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03C
Rockville, MD 20852
Telephone: (301) 496-5575
FAX:  (301) 496-3790
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants and Contracts Management Office
National Institute of Nursing Research
Building 45, 3AN-12 MSC 6301
Bethesda, MD 20892
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email: [email protected]

Daniel Milstead
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX: (301) 480-8301
Email:  [email protected]

David Mineo
Grants Management Branch
National Institute of Environmental Health Sciences
PO Box 12233
Research Triangle Park, NC  27709
Telephone: (919) 541-1373
Fax: (919) 541-2943
Email: [email protected]

Doug Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17F
Rockville, MD 20852
Telephone: (301) 496-5001
Fax: (301) 402-0915
Email: [email protected]

Although not a co-sponsor of this Program Announcement, the National Institute
of Mental Health would like to indicate its interest in applications looking at
the development, prevention and treatment of negative mental health sequelae in
low birth weight infants from diverse populations.  Of particular interest are
studies that examine developmental pathways and mechanisms through which low
birth weight interacts with other risk factors to produce negative outcomes,
intervention development studies designed to translate the findings from basic
research on pathways and mechanisms into new intervention strategies, and
intervention trials aimed at preventing and treating associated mental disorders,
behavioral and social impairments.

For further information, please contact Doreen Koretz, Ph.D., telephone (301)
443-5944.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.361 Nursing Research.  Awards will be made under the authority of the Public
Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public
Health Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies
and Federal regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

References

Collins JW Jr, Butler AG. Racial differences in prevalence of small-for-dates
infants among college educated women. Epidemiology 1997 May;8(3):315-7.

Fanaroff AA, Wright LL, Stevenson DK, Shankaran S, Donovan EF, et al. Very low
birth weight outcomes of the NICHD Neonatal Research Network, May 1991-December,
1992. Amer J Obstet Gynecol 1995; 173: 1423-31.

Le LT, Kiely JL, Schoendorf KC. Birthweight outcomes among Asian American and
Pacific Islander subgroups in the United States. Int J Epidemiol 1996
Oct;25(5):973-9.

National Center for Health Statistics (NCHS). Births, marriages, divorces and
death, 1997. MVSR 1998 Jul 28; 46(12).

Ventura SJ, Martin JA, Curtin SC, et al. Report of Final Natality Statistics,
1996. MVSR 1998 Jun 30; 46 (11S).

Offenbacher S, Katz V, Fertik G, et al.  Periodontal infection as a possible risk
factor for preterm low birth weight.  J Periodontol 1996; 67:1103-13.

Vohr BR, Dusick A, Steichen J, Wright LL, Verter J, Mele L.  Neuro-developmental
and functional outcome of extremely low birth weight(ELBW) infants.  Pediatr Res
1998;43:238A.

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